Supporting document 1 (at Final Assessment)
Risk Assessment – Proposal P274
Review of Minimum Age Labelling of Foods for Infants
Executive summary
The appropriate timing for the introduction of solid foods to infants, also termed
complementary feeding, is considered to be an important aspect of meeting an infant’s
nutritional requirements in the first year of life. Infants should be introduced to solid foods
when breastfeeding (or infant formula) no longer provides sufficient nutrients and when
developmental cues indicate a readiness to receive solid food. However, the ideal time
period to introduce solid foods in terms of various long and short term health outcomes has
been debated over the past few years.
A number of international expert bodies including the World Health Organization (WHO), the
European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN),
and the European Food Safety Authority (EFSA) have reported views on timing of
introduction of complementary feeding. The National Health and Medical Council (NHMRC)
and New Zealand Ministry of Health (NZ MOH) have also issued recommendations stating
that introduction of solid foods should occur when an infant is ‘around 6 months’ of age. This
recommendation differs from the current requirements in Standard 2.9.2 – Foods for Infants
which refers to ‘4 months’ as the minimum age for labelling infant foods.
Therefore, the main purpose of this assessment is to determine whether any food-related
safety risks would be associated with the introduction of solid foods at ‘around 6 months’
relative to ‘from 4 months’.
Long- and short-term health outcomes that have been examined in relation to the timing of
commencement of complementary feeding include nutritional adequacy (including energy
intake), growth and overweight, developmental effects (including food preferences), renal
function, infectious morbidity and allergic diseases or syndromes. Because of the many
differences and variables in study designs, it is difficult to link the specific timing (i.e. defined
in months of age) to a health outcome. The strength of evidence for many of these
associations is inconclusive due to studies where interpretation is complicated by study
objectives which are separate to complementary feeding, such as duration of breastfeeding.
Because of the increase in the numbers of children observed with food allergy, sensitisation
and anaphylaxis seen over the past 10-15 years, the association between allergic diseases
and the timing of solid food introduction is of much current interest. In 2008, FSANZ reviewed
the risk of allergy and other immune-mediated diseases in relation to timing of introduction of
solid foods and concluded that, although preliminary information suggests that a window may
exist between 4 and 7 months to minimise allergy risk, conclusive evidence was still lacking.
In 2009, reports published by EFSA and ESPGHAN gave similar conclusions.
1
The risk assessment was therefore revised by FSANZ in 2013 to review the evidence for the
appropriate timing for solid food introduction, focussing on reports and data published since
2008.
The main objectives of the 2013 assessment were to identify adverse health outcomes
associated with timing of solid food introduction relevant to the proposed change for the
labelling of infant foods as appropriate for infants ‘around 6 months’. Food allergy risks were
reviewed in detail because of current concerns, which are particularly relevant to the time
periods covered in this proposal, and also due to the availability of new research in the area.
The main conclusions of this assessment are summarised as follows:

Solid foods introduced at ‘around 6 months’ compared to ‘from 4 months’ effectively
means that introduction of solid foods could be delayed by as much as up to 2 months.
Based on several key review articles, there are no health effects that are clearly linked
with adverse outcomes if solid food is introduced from 4 months compared to delaying
until ‘around 6 months’ of age. Allergy risk appears to be associated with solid foods
introduced to infants at less than 4 months based on several cohort studies. This
association supports the current ESPGHAN and EFSA recommendations that ‘from 4
months’ is the appropriate minimum age at which solid foods are introduced.

Since 2008, there is increasing evidence that the timing of solid food introduction may
be related to the development of food-related allergy. The critical period to minimise the
risk of allergy development seems to be between the ages of 4 and <7 months.
However, because of unclear and inconsistent definitions of age categories,
measurement bias in many studies and the contribution of various other factors in the
development of allergic disease, the evidence is not conclusive. Currently, there are
randomised controlled trials (RCTs) underway which aim to determine whether
exposure to food allergens, and not avoidance, is critical during this period to minimise
the risk of developing food-related allergy and to determine the optimal timing for
introduction of solid foods.
Therefore, FSANZ concludes that there is a window from 4 to <7 months for introducing solid
food which carries a low risk of adverse health outcomes.
Health surveys conducted in Australia (2010) and New Zealand (2011/2012) show that no
more than 10% of infants are introduced to solid foods before four months of age. Of the
mothers who introduced solids to infants before four months of age the proportion was
highest among New Zealand Maori, young Australian mothers (<25 y) and the lower socioeconomic groups in Australia. There appeared to be no association between the introduction
of solids and cessation of breastfeeding.
2
Table of Contents
EXECUTIVE SUMMARY .............................................................................................................................. 1
TABLE OF CONTENTS ............................................................................................................................... 3
INTRODUCTION ................................................................................................................................... 4
1.1
OBJECTIVE OF THE ASSESSMENT ......................................................................................................... 4
1.2
SCOPE OF THE ASSESSMENT ................................................................................................................ 4
1.3
RISK ASSESSMENT QUESTIONS ............................................................................................................ 5
1.4
DEFINITIONS .......................................................................................................................................... 5
BACKGROUND TO THIS RISK ASSESSMENT ............................................................................... 5
2.1
PREVIOUS FSANZ ASSESSMENT ......................................................................................................... 5
2.2
RECOMMENDATIONS OF EXPERT PANELS AND COMMITTEES ............................................................... 6
2.3
SUMMARY OF HEALTH EFFECTS ASSOCIATED WITH TIMING OF THE INTRODUCTION OF SOLID FOODS 7
SOLID FOOD INTRODUCTION AND ALLERGY .............................................................................. 9
3.2
FSANZ ANALYSIS ON THE POTENTIAL ASSOCIATION BETWEEN THE AGE OF SOLID FOOD
INTRODUCTION AND ALLERGY .......................................................................................................................... 10
3.3
STUDIES CURRENTLY UNDER WAY (RCTS) ........................................................................................ 13
3.4
ASCIA RECOMMENDATION ON TIMING OF SOLID FOOD INTRODUCTION ............................................ 13
3.5
PREVALENCE OF FOOD-RELATED ALLERGY ........................................................................................ 13
3.6
SUMMARY ............................................................................................................................................ 14
INTRODUCTION OF SOLIDS IN AUSTRALIA AND NEW ZEALAND ......................................... 14
4.1
NEW ZEALAND NATIONAL DATA .......................................................................................................... 14
4.2
AUSTRALIAN NATIONAL DATA .............................................................................................................. 14
4.3
INTRODUCTION OF SOLIDS VS PREVALENCE OF BREASTFEEDING ...................................................... 16
4.4
SUMMARY ............................................................................................................................................ 16
CONCLUSIONS .................................................................................................................................. 16
ATTACHMENT 1: HEALTH EFFECTS ASSOCIATED WITH AGE OF COMPLEMENTARY
FEEDING ..................................................................................................................................................... 17
ATTACHMENT 2: ALLERGY AND ASSOCIATION WITH AGE OF COMPLEMENTARY FEEDING 20
ATTACHMENT 3: SUMMARY OF ISSUES CONSIDERED IN FSANZ RISK ASSESSMENTS
RELATING TO THE AGE OF INTRODUCTION OF SOLID FOODS ..................................................... 24
ATTACHMENT 4: BASIS OF NHMRC GUIDELINES FOR INFANT FEEDING ................................... 27
REFERENCES ............................................................................................................................................ 29
3
Introduction
Proposal P274 – Review of Minimum Age Labelling of Foods for Infants concerns a
proposed amendment to Standard 2.9.2 – Foods for Infants that sets the labelling
requirements for solid foods intended for infants.
The revised Australian Infant Feeding Guidelines, launched by the NHMRC in February
2013, recommended that solid foods be introduced to infants at ‘around 6 months’ (NHMRC
2012a). This recommendation is unchanged from the previous guideline issued in 2003
(NHMRC 2003). Likewise, the New Zealand Food and Nutrition Guidelines for Healthy
Infants and Toddlers also recommended introduction of solid foods at ‘around 6 months’
(New Zealand Ministry of Health 2008). The timing for the introduction of solid foods in both
guidelines is centred on ensuring adequate nutrient intake to infants when breast milk (or
infant formula) may no longer be sufficient.
1.1
Objective of the assessment
This assessment provides an update of risk assessment work completed in 2008 and
published as part of the Preliminary Final Assessment Report (PFAR) associated with
Proposal P274 (FSANZ 2008) in relation to the timing of solid food introduction to infants.
This assessment aims to:



1.2
summarise the key conclusions of the PFAR
summarise reviews or reports of international expert panels which have considered
timing of complementary feeding for infants
review published scientific data (particularly since 2008) that underlies Australian and
New Zealand national infant feeding guidelines with emphasis on the induction of food
allergy and/or gluten intolerance.
Scope of the assessment
Infant as defined under Standard 2.9.2 means a person up to the age of 12 months. Infant
feeding practices up to the age of 12 months include breastfeeding, formula-feeding and, at
an appropriate age, solid foods. Proposal P274 is relevant to the labelling requirements of
foods intended for infants and this assessment will be directed at health effects associated
with the time period over which solids are first introduced. The health benefits of
breastfeeding (exclusive or mixed with formula-feeding) for infants up to 6 months of age are
well recognised and will not be addressed. Similarly, the inadvisability of introducing solids
before 4 months of age is well recognised and will not be addressed.
Previously, FSANZ considered whether delaying solid food introduction to around 6 months
of age would have an adverse impact on a range of nutritional and developmental outcomes
for infants (see Section 2.1) (FSANZ 2008). This assessment applied a tiered approach to
determine whether there was recent research that might alter the previous conclusions. We
considered several reviews of a broad range of health outcomes that were claimed to be
linked to the timing of solid food introduction (see Section 2.3) and concluded that most were
related to the introduction of solids before 4 months or were related to the use of infant
formula. Only the risk of developing allergic diseases was identified as an area where newly
available literature might change previous conclusions made in 2008. The literature was
reviewed to update the previous consideration of this topic (See Section 3).
4
1.3
Risk assessment questions
The risk assessment question addressed in this assessment (covered in Section 3) is:
What conclusions can be drawn from the evidence on the association between
the age of introduction of solid food and the development of food-related
allergies and/or gluten intolerance in children?
It also describes the age at which solids are introduced in Australia and New Zealand and
considers whether this is associated with cessation of breastfeeding (Section 4).
1.4
Definitions
The following definitions apply to this risk assessment:
Atopy A child with atopy produces IgE antibodies after exposure to common environmental
allergens. The atopic diseases (eczema, asthma and rhinoconjunctivitis) are clinical
syndromes each defined by a group of symptoms and signs (Gold and Kemp 2005).
Complementary feeding is defined as the gradual introduction of solid food and fluids along
with the usual milk feed (breast milk or infant formula) to an infant’s diet (New Zealand
Ministry of Health 2008).
Exclusive breastfeeding refers to the WHO recommended definition which is breastfeeding
with no additional liquid or solid foods other than vitamins and medications (Binns et al.
2009).
Food allergy (or food-related allergy) refers to food-mediated adverse reactions that involve
the immune system resulting from oral exposure to food (Hayder et al. 2011).
Food sensitisation is an immune response to food allergen exposure which precedes
development of food allergy.
Background to this risk assessment
2.1
Previous FSANZ assessment
The previous Proposal P274 nutrition assessment (FSANZ 2008) examined the following
nutritional and developmental outcomes if introduction of solid foods were delayed to ‘around
6 months’:




the potential for displacement of human breast milk and/or infant formula, any changes
in energy intake, and whether growth outcomes are adversely affected
the capacity of infant kidneys to deal with the higher solute load of solid foods prior to 6
months of age
the impact on iron and zinc status, particularly in pre-term infants
the influence of feeding practices during infancy on later food preferences.
The assessment concluded that in terms of infant growth, kidney function, and iron/zinc
status, it is unlikely that there are differences in the nutritional and developmental outcomes
for infants that receive solids at an early (close to 4 months) versus a later (close to 6
months) age.
5
In addition, the relationship between age of introduction of solid foods and the development
of allergies was assessed. Conclusions in this assessment, however, were more uncertain
with some evidence suggesting that the delay in the introduction of solid food to infants’ diet
may contribute to the risk of developing allergy and other immune-mediated diseases.
FSANZ noted in the 2008 report that this was an active area of research that, once
published, was likely to increase the confidence around the optimal age for complementary
feeding.
2.2
Recommendations of expert panels and committees
Recommendations on the appropriate age for the introduction of solid foods to infants have
been issued by the World Health Organization (WHO) and several international scientific
panels including the European Society for Paediatric Gastroenterology, Hepatology, and
Nutrition (ESPGHAN) and the European Food Safety Agency (EFSA). The views of these
expert panels are based on consideration of several health outcomes and consensus on the
benefits of breastfeeding for the first 6 months1. However, recommendations are somewhat
inconsistent for starting complementary feeding where timing of solid food introduction varies
from 4 months compared to ‘around’ or ‘at’ 6 months of age (Table 1). These are subtle
differences but may be important for certain health outcomes (addressed in Section 2.3).
Table 1: Comparison of recommendations for age of complementary feeding from
Expert Panels and Committees
Expert Body
WHO (2003)
1
Recommendation
Recommends infants start receiving complementary foods at 6 months of age in
addition to breast milk
ESPGHAN
(2009)
Complementary feeding should not be introduced in any infant before 17 weeks and
all infants should start complementary feeding by 26 weeks.
EFSA
(2009)
Complementary food introduced between the age of 4 and 6 months is safe and
does not pose a risk for adverse health effects.
NZ MOH
(2008)
Recommends that infants be fed exclusively on breast milk to around six months of
age, at which time complementary foods can be introduced with continued
breastfeeding.
NHMRC
(2013)
Recommends introduction of solid foods at around 6 months of age.
The NHMRC recommendation is based on systematic reviews (NHMRC 2011) conducted as
part of the review for the Australian Dietary Guidelines. The findings of the systematic
reviews were used to inform the 2013 NHMRC Infant Feeding Guidelines which were
published at the same time (NHMRC 2012a). A detailed summary of the evidence base of
the NHMRC guidelines is provided at Attachment 4.
1
The WHO defines complementary feeding as foods or liquids that are provided along with breast milk and thus, infant
formula is categorised as a complementary food. The intention of the WHO definition is to encourage exclusive
breastfeeding until 6 months, particularly in developing countries where risk of infection from unsanitary food and water is
significant (WHO 2003). In contrast, ESPGHAN and EFSA and others define complementary foods as all solid food and
liquid foods other than breast milk or infant formula and follow-on formula. This assessment follows the ESPGHAN/EFSA
definition.
6
The initial literature search for the Australian Dietary Guidelines revealed evidence on the
relationships between age of introduction of solid foods and development of overweight and
development of allergic symptoms.
Subsequent systematic reviews on these two relationships indicated that:
(1)
Overweight or obesity in children younger than 7 years of age, based on limited
information (1 systematic review and 2 cohort studies; Grade D evidence2) showed “no
relationship between the age of weaning and development of infant or child
overweight”.
(2)
Development of allergic disease, based on limited information (1 systematic review, 2
RCTs, and 4 cohort studies; Grade D evidence), may be associated with the risk of
allergic disease with some evidence that delaying the introduction until after 6 months
may increase the risk of certain allergies. Details on the NHMRC review covering
allergic syndromes is summarised in Section 3.
The NHMRC Infant Feeding Guidelines recommend introduction of solid foods at around 6
months based on the nutritional sufficiency of breast milk until 6 months of age, development
of feeding behaviour to allow chewing and swallowing and maturity of the digestive system
(see Attachment 4).
2.3
Summary of health effects associated with timing of the
introduction of solid foods
ESPGHAN and EFSA published comprehensive reviews on timing of complementary
feeding in relation to a number of potential health effects (Agostoni et al. 2008; EFSA Panel
on Dietetic Products Nutrition and Allergies (NDA) 2009). In addition, Hornell et al recently
published a systematic review on infant feeding practices and covering similar health effects
(Hornell et al. 2013). Attachment 1 lists the key findings from each review. Specific health
outcomes examined included nutrient adequacy (including energy), growth (including obesity
and overweight), allergic diseases and infectious morbidity. The combined findings of these
reviews indicate that:

Deficiency of iron or zinc is unlikely if solid foods are introduced in the period of 4-6
months. However, data are lacking on nutrient intakes and hence nutritional status if
solids are introduced after 6 months.

Age at which solid food is introduced does not have a strong impact on growth rates
(weight or length) but data are lacking for solid foods introduced after 6 months.
Interpretation of studies is complicated by differences in growth that result from
changes in dietary composition (e.g. different complementary foods or increased milk
protein).

The evidence is insufficient to demonstrate that the timing of solid food introduction
affects the risk of obesity or overweight. A subsequent systematic review on the timing
of complementary foods and obesity risk concluded that there is no increased risk if
foods are introduced at 4–6 months or >6 months but that there is some evidence that
very early introduction (before 4 months) may increase the risk of childhood
overweight (Pearce et al. 2013).
2
Appendix E of the Australian Dietary Guidelines states that Grade D indicates that the evidence was limited,
inconclusive, or contradictory. These Grade D relationships were not used to inform the development of the
Guidelines.
7

Solid food introduction before 6 months of age is a significant risk factor for infectious
diseases in developing countries. In developed countries this association has been
examined in terms of non-exclusive breastfeeding rather than introduction of solids.
An association with introduction of solids to infants less than 4 months of age has been
observed in one cohort study conducted in Belarus (Kramer et al. 2003) but not in a
study conducted in the UK (Quigley et al. 2009).

Increased risk of allergic syndromes (food allergy, atopy, gluten intolerance and/or
celiac disease, and asthma) may be associated with the timing of complementary
feeding, particularly if solid foods are introduced outside the 4–6 month period.
For the purposes of Proposal P274, analysis of studies on links between infant feeding
practices and certain long- and short-term health outcomes is not straightforward. Studies
frequently consist of double-barrelled questions and/or definitions so that health effects may
be related to more than one issue. For example, studies focussed on determining the
optimal duration of breastfeeding are important for understanding numerous infant health
issues. However these same studies do not necessarily reveal the appropriate age for the
introduction of solid foods. Very few studies have assessed the timing of complementary
feeding as an independent risk factor. Specific factors contributing to definitional problems in
studies examining the timing of solid food introduction include the classification of formula as
a complementary food, studies conducted solely on breastfed infants with no comparison
with formula-fed infants, and extrapolation of evidence from studies in developing countries
to developed countries.
As an example of such definitional problems, the current WHO infant feeding guidelines are
based in part on the ‘PROBIT’ observational cohort study which found lower gastrointestinal
rates infection in infants exclusively breastfed for at least 6 months (Kramer et al. 2003).
However, in relation to solid food introduction, the ‘PROBIT’ study only examined two
populations: infants exclusively breastfed for 6 months and solid food introduced thereafter
compared to infants exclusively breastfed for 3-4 months then solid foods and/or formula
introduced. The incidence of gastrointestinal infection in infants who were introduced to solid
foods at 3–4 months while continuing to be breastfed or after adjusting for the use of
breast milk versus formula was not determined in this study. Therefore it is not possible to
separate the effect of solids from the effect of formula on gastrointestinal infection incidence
in the group with shorter breastfeeding duration in the PROBIT study.
By contrast, the UK Millennium Cohort Study examined hospitalisation rates for
gastrointestinal and lower respiratory tract infections separately for age of introduction of
solids and from use of formula (Quigley et al, 2009) and adjusted the analyses. The results
show lower hospitalisation rates are associated with breastfeeding compared to use of
formula, but there is no association with age of introduction of solids for the two conditions
studied. The authors reported:
We assessed the independent effects of solids and breastfeeding on the risk of hospitalisation
for infection in term, singleton infants in the Millennium Cohort Study (n=15,980). For both
diarrhoea and lower respiratory tract infection (LRTI), the monthly risk of hospitalisation was
significantly lower in those receiving breast milk compared with those receiving formula. The
monthly risk of hospitalisation was not significantly higher in those who had received
solids compared with those not on solids (for diarrhoea, adjusted odds ratio=1.39, 95% CI:
0.75-2.59; for LRTI, adjusted odds ratio=1.14, 95% CI: 0.76-1.70), and the risk did not vary
significantly according to the age of starting solids. (Quigley et al, 2009, emphasis added).
FSANZ has not identified any data that can be examined to determine if there is a difference
in gastrointestinal infection rates in Australia and New Zealand according to whether infants
were introduced to solid foods from 4 months or around 6 months of age.
8
Such data would be difficult to interpret in any case, as it would be confounded by other
factors, such as infants in this age group moving into childcare. FSANZ believes that the
data from the UK Millennium Cohort Study are likely to be more relevant to prevailing
conditions in Australia and New Zealand than data from Belarus.
Apart from the potential links to allergic diseases, the three reviews covered in Attachment 1
indicate that there are no new data to change the view that there are no health effects clearly
linked with adverse outcomes if solid food introduction is delayed to ‘around 6 months’
compared to from 4 months of age (see Attachment 1). There are new studies and reviews
(Palmer and Prescott 2012) examining the potential association to allergic diseases
published since the 2008 FSANZ assessment (FSANZ 2008). As this is an area of active
research with new data which might alter previous conclusions, a more detailed analysis of
this health effect is addressed in Section 3.
Solid food introduction and allergy
Allergy is an abnormal immune response to a variety of exogenous proteins such as pollen,
insect venom and food proteins. The development of allergic diseases is complex and
depends on interactions between a variety of environmental factors and the genetic
susceptibility of the individual. For food allergy3, avoidance of potentially allergenic foods
was originally considered to be important for susceptible individuals. Scientific evidence no
longer supports this approach and oral tolerance (suppression of orally-induced immune
responses in the gut) and timing of introduction and dose of potential food allergens are
thought to be critical factors (Brandtzaeg 2010).
Common allergenic foods are cows’ milk protein, egg, soya, wheat, nuts and fish. Food
allergy is an IgE-mediated immune response which is characterised by clinical outcomes or
diagnoses such as atopic eczema (atopic dermatitis), allergic rhinitis and asthma. Food
protein sensitisation precedes development of food allergy but does not always lead to an
allergic disease for a given food.
For example, eczema is also a clinical symptom of food sensitisation, usually appearing in
the first 18 months of age, which infants may outgrow in later childhood. Allergies to proteins
in milk and egg increase risk of sensitization to pollen and development of asthma so that
these health outcomes are also considered as food related.
The relationship between allergic disease and infant feeding has been covered in several
recent reviews papers (Prescott et al. 2008, Prescott and Nowak-Wegrzyn 2011, Lack and
Penagos 2011, Fewtrell et al. 2011, Palmer and Prescott 2012). The prevalence of allergic
diseases and syndromes in children has increased substantially in the past 10–15 years.
The cause of this increase is not known but exposure to food proteins is considered to be an
underlying risk factor, with the type of food protein, exposure through the maternal diet and
the timing of exposure to specific food proteins under investigation. In addition, infants
exposed to food proteins too early may develop allergic disease due to inefficient digestion
of food proteins, undeveloped gut permeability and degree of gut bacterial colonization
(Shreffler and Radano 2011).
3
Food-related allergy includes gluten intolerance which is an immune-mediated response to proteins in gluten
and can give rise to celiac disease and Type 1 Diabetes Mellitus (FSANZ 2008).
9
3.1
NHMRC review on age of introduction of solid foods and
allergies
The relationship between development of allergies and appropriate timing for the
introduction of solid foods was addressed within both the NHMRC Infant Feeding Guidelines
(NHMRC 2012a) and the Australian Dietary Guidelines (NHMRC 2013). The underlying
scientific data supporting these guidelines was described in the Literature Review (NHMRC
2012b) for the Infant Feeding Guidelines and the Evidence Report (NHMRC 2011) for the
Dietary Guidelines.
The Literature Review for the Infant Feeding Guidelines considered the relationship of
breastfeeding and formula-feeding to the prevention of atopic diseases and not timing of
solid food introduction. However, the views and recommendations of various expert groups
on the relationship between allergies and solid foods were also reviewed. Final comments
suggested that there is no reason to restrict the introduction of any particular foods or groups
of food to infants to prevent allergy or promote tolerance.
The Evidence Report for the Australian Dietary Guidelines was based on systematic reviews
addressing specific targeted questions on food, diet and disease/health relationships,
including whether the age of solid food introduction in children is associated with the
development of allergic syndromes (NHMRC 2011). The literature searches identified seven
studies of which only four cohort studies and one RCT, all published between 2006 and
2008, were judged to be of suitable quality. Only two of the five studies examined
introduction of solid foods in the 4–6 month time period and the other three involved
introduction of solids after 6 months. The review concluded that the data suggests that
delaying solid food introduction until after 6 months may increase the risk of certain allergies
but acknowledged that the conclusion is based on a limited number of studies (Grade D
evidence).
3.2
FSANZ analysis on the potential association between the age
of solid food introduction and allergy
The analysis of review papers shown in Attachment 1 indicated that the age of introduction
of solid foods is potentially associated with the development of allergic disease. This
potential link was also identified in the FSANZ assessment conducted in 2008 (FSANZ
2008) and is consistent with recent published reviews (Palmer and Prescott 2012). Current
concerns about food allergy risk are also particularly relevant to the time periods covered in
Proposal P274. Therefore, a more detailed analysis of the evidence for this association is
described below.
Sources of data, search strategy
Primary research (cohort study or RCT) was selected according to the PICO4 method and
included the following study characteristics:
(1)
(2)
(3)
4
Breastfed or formula-fed infants of normal allergy risk or at-risk of allergic disease
(parental history, allergic symptoms).
Various solid foods or specific allergenic foods (but not infant formula) introduced from
4 months of age.
Depending on the study, age of solid food introduction was compared to another
specified age (e.g. introduction at 4 months compared to 6 months) or a non-allergenic
food (e.g. egg compared to rice powder).
PICO defined as population (P), intervention (I), comparison (C) and outcome(s) (O).
10
(4)
(5)
Outcomes were clinical diagnoses in infants and children up to age 10 years of foodrelated allergic diseases or symptoms: asthma, atopy or atopic disease, allergic
rhinitis, allergic sensitisation, coeliac disease; Type 1 diabetes mellitus; eczema; food
allergy, food sensitisation, and wheezing.
Studies or specific analyses within studies that examined the duration of breastfeeding
and association with allergic diseases were excluded.
The following strategy was used to source primary research:
(1)
(2)
(3)
(4)
Studies cited by reviews conducted by expert bodies (EFSA, ESPGHAN, the American
Academy of Pediatrics (AAP), NHMRC). These mainly covered the period up to 2008
when these reports were completed or published.
Studies cited by Palmer and Prescott (2012) which covers the period from 2008 to
2012.
Studies identified by searching PubMed database using search terms infant feeding,
allergy, solid foods, complementary feeding plus related terms for the period 2008 to
July 2013.
Include only primary studies; position or consensus statements and review articles
(apart from Palmer and Prescott, 2012) were excluded.
Studies identified through this approach are listed in Attachment 2. In summary, 27 studies
covering the period of 1981–2013 were reviewed. Most were prospective cohort studies
including infants of normal or increased allergy risk. The studies measured numerous
allergic disease outcomes in infants and children spanning 1–10 years of age. The search of
the PubMed database identified four additional studies published in 2013 not included in the
other reviews (Palmer et al. 2013; Frederiksen et al. 2013; Nwaru et al. 2013a; Nwaru et al.
2013b).
One systematic review on the association of complementary feeding with the development of
allergy was included in Attachment 2 (Tarini et al. 2006). The review’s conclusions were
based on some of the primary research cited in this assessment plus several earlier
publications. Allergy outcomes in relation to duration of breastfeeding have also been
covered in several recent large systematic reviews (Kramer and Kakuma 2002; Kramer and
Kakuma 2012) but, as mentioned in section 2.3, definitional issues mean that these reviews
have limited use for Proposal P274.
Results
Comparing studies is complicated by the variety of foods, timing of solid food introduction,
allergy risk, different allergy outcomes and age at assessment of outcome. To simplify
analysis of these studies and address the question about the appropriate timing of solid food
introduction, studies in Attachment 2 are grouped according to outcome:
(1)
(2)
(3)
Evidence that introduction before 4 months increases risk of allergic disease compared
to introduction after 4 months.
Evidence shows no association (protective or adverse) between the timing of solid
food introduction and risk of allergic disease.
Evidence that introduction of solid foods at around 6 months (i.e. after 4 months and
before 7 months) is associated with decreased risk (or no increased risk) of allergic
diseases compared to outside this age range.
Introduction of solid foods before four months increased the risk of eczema in six cohort
studies conducted from 1981 to 1994. These studies were mostly small cohort studies and
most were also centred on the protective effects of exclusive breast feeding.
11
These results are difficult to interpret because exclusive breastfeeding is often encouraged
for at-risk infants (e.g. family history of allergic diseases) and so the results could reflect
reverse causation (Zutavern et al. 2006).
The evidence that allergy risk appears to be associated with solid foods introduced to infants
at less than 4 months combined with evidence that risk of infectious morbidity (based on
evidence of protective effects of breastfeeding) is also increased with this time period,
continues to support the current recommendations from ESPGHAN, EFSA, AAP and
NHMRC that 4 months of age is the appropriate minimum age at which solid foods are
introduced.
Seven studies carried out from 1983 to 2011 showed neither protective nor adverse effects
related to the age of solid food introduction and the risk of allergic disease. The lack of
association was measured across various allergic diseases or symptoms and included one
systematic review of 13 cohort studies (Tarini et al. 2006) showing association between the
introduction of solids before the age of 3–4 months and development of eczema. However,
little data were available to support an association between early introduction of solid food
and other allergic conditions. A comparatively large cohort study (Chuang et al. 2011)
showed that solid food introduction before 4 months, between 4–6 months, and after 6
months was not related to the risk of atopic disease in infants up to 18 months of age. Given
the number of participants, this study provides strong support that the timing of solid food
introduction across the period of ‘around 6 months’ does not influence the development of
atopic diseases. The study recruited participants from the general population of newborn
infants but excluded those with physician-diagnosed atopic dermatitis in the first 6 months of
life to eliminate contribution of reverse causality. The inclusion of children with apparent
normal allergy risk, however, may mean that immune-mediated food sensitisation, which
underlies development of allergy, may not have occurred in these infants. These issues
indicate the complexities in designing and interpreting studies on the development of
allergies linked to dietary factors.
A number of studies (12 as listed in Attachment 2) published more recently (2006 to present)
suggest growing evidence that exposure to allergenic foods between 4–6 months and/or
before 7 months may decrease the risk of allergic diseases. As previously highlighted,
mainly prospective, cohort studies have been conducted involving various time points, types
of foods, and allergenic outcomes. These studies also support the view that avoidance of
food allergens does not prevent allergic disease and that exposure to food in the period
between 4 and 7 months may actually result in ‘tolerance’ rather than allergy.
The main conclusion from the 2013 assessment was that, aside from the question of allergy,
there were no adverse health effects that are clearly linked if solid food introduction is
delayed to ‘around 6 months’ compared to ‘from 4 months’. Based on FSANZ’s review of
primary research that was published between 1981 and 2013, the critical period for
introduction of solids, to minimise the risk of allergy development, seems to be between the
ages of 4 and <7 months. However, there are increased risks of allergy with solid foods
introduced to infants less than 4 month. There may also be increased risk of allergy
development when solids are introduced at 7 months or later. This latter conclusion is
consistent with the NHMRC evidence statement “Delay in the introduction of solid foods until
after the age of 6 months is associated with increased risk of developing allergic syndromes.
(D)” (NHMRC 2011). The additional studies included in the FSANZ update might even
increase the rating of this statement to C (suggestive) from D (inconclusive).
12
3.3
Studies currently under way (RCTs)
Prescott and Palmer (2012) highlight the main issues with conclusions based on
observational cohort studies conducted to date. Many studies on timing of complementary
feeding do not account for ‘reverse causation’ which arises when an allergy outcome
influences the exposure.
For example, the children of allergic parents or infants showing early signs of allergy
(eczema, for example) may be prescribed specific feeding practices (e.g. delayed solid food
introduction) that are then interpreted as causative for increased risk of allergenic diseases
measured at later time points (Zutavern 2006).
Most recent observational studies attempt to correct for reverse causation (e.g. Chuang et
al, 2011) but numerous other factors are also not tested or controlled including timing of
specific foods, quantity and quality of solid foods, influence of maternal exposure or
environmental factors, and other routes of early allergen exposure that contribute to oral
tolerance (Shreffler and Radano 2011; Lack and Penagos 2011). Several randomised
controlled trials are now currently underway which will examine some of these factors and
test the hypothesis that ‘early’ regular exposure to food allergens induces oral tolerance and
reduces the risk of allergic disease (Palmer and Prescott 2012; Metcalfe et al. 2013).
Interventions involve introduction of various foods in the range of 3–8 months but with a
clear focus on the 4–6 month period. Mostly results are yet to be published. In support of the
early exposure hypothesis, recent results from a small RCT showed that the incidence of
egg allergy at one year was reduced in sensitised infants fed egg protein from 4 months
compared to infants on a normal diet with egg introduced at 8 months (Palmer et al. 2013).
3.4
ASCIA recommendation on timing of solid food introduction
The Australasian Society for Clinical Immunology and Allergy (ASCIA) issued a position
statement on allergy and infant feeding based on systematic review of relevant papers and
recommendations by other expert panels (ESPGHAN and AAP) (ASCIA 2010). Based on
current evidence, ASCIA concluded that there is little evidence that delaying introduction of
solid foods beyond 6 months reduces the risk of allergy and current expert reviews support
the recommendation that solid foods should be introduced from around 4–6 months. The
ASCIA statement also suggests that delays in solid food introduction beyond 6 months may
actually increase the risk of allergy development but acknowledges that more research is
needed to make conclusive recommendations about the timing of introduction of solid foods.
ASCIA recommendations are based on primary studies and review articles as cited in their
assessment.
3.5
Prevalence of food-related allergy
As Proposal P274 relates to infant foods which can be fed to all populations of infants, the
specific question of effects on at-risk populations was not addressed. However, studies
reviewed in SD1 (see Appendix 2 table) covered the association between the timing of solid
food introduction and allergy risk in both at-risk (e.g. having allergic symptoms or at least
one direct family member with allergic disease) and normal risk populations. Increased risk
of allergies in relation to the timing of solid food introduction is found in both populations.
A recent paper from the HealthNuts research program (Osborne et al. 2011) measured the
prevalence of food-related allergy in one-year old Victorian children, as assessed by the
‘gold standard’ oral challenge test, to be at least 10%.
13
Also from this research group, the population prevalence of physician-diagnosed eczema5
at 12 months was recently reported as 20% (Martin et al. 2013) At-risk infants are generally
defined as having one immediate family member with a history of any allergic disease
(Koplin et al. 2013) On this basis, prevalence of allergy among at-risk infants could be much
higher (Su et al. 2012) although an accurate determination of this is difficult due to complex
aetiology of allergic diseases.
Nevertheless, the development of food-related allergies in infants and children is a
significant public health problem. As noted above, several RCTs that are currently underway
aim to determine whether ‘early’ regular exposure to food allergens induces oral tolerance
and reduces the risk of allergic diseases.
3.6
Summary
Overall the evaluation of the studies listed in Attachment 2 suggests that the risk of allergic
diseases or syndromes in children and infants to food is mainly linked to introduction of
solids before 4 months and, possibly, after 7 months of age. Based on available evidence,
the introduction of solid food at ‘around 6 months’ does not appear to present a greater risk
of subsequent food allergy, relative to the introduction of solid food ‘from 4 months’. This
conclusion is consistent with current advice and recommendations issued by several expert
bodies. However, as concluded in the PFAR for Proposal P274 (FSANZ 2008), evidence
continues to emerge that the period of 4–7 months may be the critical window for the
prevention of food-related allergy. Most of the evidence is limited to observational cohort
studies and current efforts are focussed on appropriate studies designed to address the
specific questions of timing of complementary feeding in relation to allergy. These include
several RCTs currently underway.
Introduction of solids in Australia and New
Zealand
4.1
New Zealand national data
The New Zealand Health Survey 2011/2012 showed fewer infants were given solid food
before 4 months of age (10%) than in 2006/07 (16%) (Ministry of Health 2012). In addition,
the percentage of Maori children that were given solid food before 4 months of age had
fallen from 22% in 2006/07 to 16% in 20011/12. The New Zealand Food and Nutrition
Guidelines for Healthy Infants and Toddlers (Ministry of Health 2008) recommend that
complementary foods be introduced at ‘around 6 months’ (they had previously
recommended 4 to 6 months). The Guidelines also recommend that solid foods should be
introduced when an infant is at the appropriate stage of development, which will vary from
infant to infant.
4.2
Australian national data
The 2010 Australian National Infant Feeding Survey (Australian Institute of Health and
Welfare 2011a) assessed the age of introduction of solid foods in two different ways (Table
2). First, when asked about the day before the survey, 9.7% of mothers with infants aged
3–<4 months had fed their infant solids (n=3,887 mothers). In the second method, when
asked to recall the age of introduction, 4.3% of respondents with an infant aged 4 months or
older reported having introduced solids before 4 months (time-to-event analysis using
responses from all mothers).
5
Eczema is also known as atopic dermatitis, atopic disease or IgE-associated eczema and is an inflammatory,
non-contagious, skin disorder which is linked to food allergy (Gold and Kemp, 2005)
14
Also shown in Table 2, solids were introduced at 3–<4 months of age in 15.2% of infants
with a mother aged 24 years or younger and in only 2.8% of infants whose mother was aged
35 years or older. There was under sampling of low socioeconomic status (SES)
respondents with infants and those with low maternal age. If the national average is reweighted using the national SES and maternal age at birth data (see Table 3.1 in:
(Australian Institute of Health and Welfare 2011b)), then FSANZ estimates that the revised
prevalences of introduction of solids before 4 months is 4.7% (SES weighting) and 6.0%
(maternal age weighting).
Variation by jurisdiction ranged from 5.9% in Queensland to 2.3% in the ACT. FSANZ has
confirmed the interpretation of these results with the Australian Institute of Health and
Welfare. Therefore FSANZ concludes that for the Australian population, the proportion of
infants who were receiving solids before 4 months of age ranged from 4–10%, noting that
within this range there was some variation according to maternal age and SES.
Data from the Queensland Infant Nutrition Surveys for 2003 and 2008 (provided by
Queensland Department of Health) shows a decrease in the proportion of infants receiving
solid food before 4 months of age (48.5% to 12.3%), over this time period – and also a
decrease in the number of infants who were introduced to solids after 6 months of age (12.1
to 8.3%). Before 2003, the recommended age to introduce solids was 4–6 months and this
changed to ‘around 6 months’ in 2003.
Table 2: Selected infant feeding data from the 2010 Australian National Infant Feeding
Surveya
Proportion of infants introduced to solid foods by age (%)
Among infants
Age
Proportion
Proportion
aged
(completed
receiving any
received solid
(months)
months)
breast milk b,KM foods in previous
24 hours c,X
Birth-<1
0 (< 1 month)
90.2
0.0
Proportion who
had ever received
solid foods d,KM
0.1
1.0-<2
1
74.6
0.7
0.1
2.0-<3
2
72.7
2.2
0.8
3.0-<4
3
70.3
9.7
4.3
4.0-<5
4
68.7
35.3
28.4
5.0-<6
5
62.9
70.2
56.2
6.0-<7
6
60.1
91.5
91.6
c
Proportion of infants introduced to solid foods by maternal age (%):
Mother’s/carer’s
age (years)
Infants age at which solid food was introduced (months of age)
<1
1–<2
2–<3
3–<4
4–<5
5–<6
6–<7
24 or younger
0.3
0.4
3.1
15.2
54.6
71.9
94.1
25 – 29
0.1
0.2
1.0
6.0
34.4
63.4
93.4
30 – 34
_
0.1
0.5
2.9
26.6
57.0
92.2
35 or older
0.1
0.2
0.5
2.8
22.4
48.9
89.9
All ages
0.1
0.1
0.8
4.3
28.4
56.2
91.6
a
Source: (Australian Institute of Health and Welfare 2011a)
From: Table 2.1 Proportion of children receiving any breast milk, by age.
From: Table 2.4 Proportion of children who had received soft/semi-solid/solid food in the last 24 hours, by current age.
d
From: Table 3.13 Proportion of children who were introduced to soft/semi-solid/solid food by month of age.
X
Cross-sectional analysis of children of this age on the day of the survey.KM Kaplan-Meier time-to-event analysis using data
from all respondents.
b
c
15
4.3
Introduction of solids vs prevalence of breastfeeding
When examining this question it is important not to use the self-referential definition of
exclusive breastfeeding. Exclusive breastfeeding is defined by the WHO as no other food or
drink, not even water, except breast milk (including milk expressed or from a wet nurse)
(WHO 2014). Once solid foods are introduced, by definition, the period of exclusive
breastfeeding is ceased.
However this does not mean that risks associated with replacement of breast milk with
formula also apply to the addition of solids to the diet for infants consuming breast milk. The
two reasons why exclusivity of breastfeeding might cease need to be assessed separately
because they do not necessarily have the same risks. For the current proposal, only
cessation of exclusivity due to introduction of solids is relevant. This section examines
whether introduction of solids is associated with cessation of any breastfeeding (i.e.
switching to using formula) which would be an indirect effect of introduction of solids on
health.
Data on infant feeding practices in Australia indicate that there is little association between
the introduction of solid foods and continuation of breastfeeding (Table 2). Between 4–6
months of age, the prevalence of any breastfeeding declines from 69% to 60% while the
prevalence of feeding solids rises to over 90%. Similarly, before 4 months of age, the decline
in the prevalence of breastfeeding is double the prevalence of introducing solids. Similar
data was not available from the New Zealand children’s health survey (Ministry of Health
2012).
4.4
Summary
In both countries, 10% or fewer infants are introduced to solids before four months of age.
This proportion appears to have declined compared to earlier surveys. The proportion was
higher in Maori in New Zealand (16%) and in lower socio-economic groups in Australia
(23%) or for mothers aged less than 25 years. Adjusting the Australian data for lower
response rates in the latter group does not alter the national prevalence. There is little
association between the introduction of solids and cessation of breastfeeding in Australia.
Conclusions
Australian and New Zealand authorities (New Zealand Ministry of Health 2008; NHMRC
2012a) recommend introduction of solid foods to the infant diet at ‘around 6 months’ of age,
largely based on assessment of the benefits of breastfeeding to this age.
A FSANZ review in 2008 found that there are unlikely to be differences in the nutritional and
developmental outcomes for infants that receive solids at an early (close to four months)
versus a late (close to six months) age. This is consistent with the updated assessment
that there are no health effects that are clearly linked with adverse outcomes if solid food is
introduced from 4 months compared to delaying until ‘around 6 months’ of age, across a
range of health outcomes including infectious morbidity, growth and micronutrient intake.
The evidence in relation to age of introduction of solids and subsequent development of
allergic disease is uncertain but, based on current evidence, there does not appear to be any
difference in risk of allergic disease when solids are introduced at any time within a critical
window of 4–<7 months of age. There is some evidence that introduction before 4 months of
age, and possibly after 7 months of age, is associated with increased allergy risk. Ongoing
research in this area may help to clarify this relationship, when the research becomes
available.
16
Attachment 1: Health effects associated with age of complementary feeding
Table A1. Summary of the key findings and conclusions from three recent reviews on the timing of solid food introduction to infants and risk of
adverse health outcomes. BF = breast feeding; EBF = exclusive breastfeeding; FF = formula-feeding; CF = complementary feeding.
KEY FINDINGS: EVIDENCE THAT SOLID FOOD INTRODUCTION AT ‘AROUND 6 MONTHS’ MAY CONTRIBUTE TO ADVERSE HEALTH OUTCOMES
ESPGHAN1
EFSA (2009)1
HORNELL ET AL (2013)2
CONCLUSION BASED ON
COMBINED FINDINGS OF
THESE REVIEWS
Review Type
Medical Position
Scientific Opinion
Systematic review
Main focus
Complementary feeding
Complementary feeding
Duration of exclusive breast
feeding
Health effect:
Energy
intake
Age of CF not specifically
addressed.
Insufficient data – age of CF in
terms of energy intake needs to
be decided for individual infant
(larger infants have greater
energy requirements).
Reviewed studies on whether
EBF provides adequate nutrients
to 6 months; concludes that
some infants need CF at 4–6
months for Fe and Zn
sufficiency.
CF introduced before 6 months
does not have strong impact on
growth rate. Late introduction
(after 6 months) may reduce
length and weight gain.
Insufficient data to make
conclusion
Association to duration of EBF
examined: EBF to 6 months
meets energy requirements and
does not compromise infant
growth.
Not addressed.
Either no association or
insufficient data to indicate the
energy intake is compromised by
age of introducing CF.
EBF for 4 months gives similar
growth rates compared to EBF
for 6 months.
No evidence of association
between CF introduced at 4–6
months and growth rate.
Not addressed.
Insufficient data to make
conclusion
Nutritional
adequacy
Growth
Neurodevelo
pment
Timing of CF not specifically
addressed although concluded
that nutritional deficiencies
during CF period (defined as
after 17 weeks and before 26
weeks) are unlikely.
Minimal evidence that solid foods
introduced at 4–6 months affects
growth.
No specific data on age of CF
reviewed but limited evidence
that low intake of LCPUFA (oily
fish) and Fe may have adverse
effect on neurodevelopment.
17
No association but some infants
may require solid foods at 4–6
months for Fe and Zn
sufficiency.
KEY FINDINGS: EVIDENCE THAT SOLID FOOD INTRODUCTION AT ‘AROUND 6 MONTHS’ MAY CONTRIBUTE TO ADVERSE HEALTH OUTCOMES
ESPGHAN1
Food
preferences
Renal
function
Obesity,
cardiovascul
ar disease
(CVD), and/or
Type II
diabetes
(T2D)
Allergy,
atopic
disease,
and/or
asthma
Celiac
disease (CD)
and/or Type I
diabetes
mellitus
(T1DM)
Infectious
morbidity:
acute otitis
media (AOM)
and/or
gastrointesti
nal
EFSA (2009)1
HORNELL ET AL (2013)2
CONCLUSION BASED ON
COMBINED FINDINGS OF
THESE REVIEWS
Insufficient data to make
conclusion
Age of CF not addressed but CF
without added sugars and salt
recommended.
Evidence indicates that renal
function is sufficiently mature to
metabolise nutrients from CF by
the age of 4 months.
Reviewed data on energy-dense
complementary foods and
protein intake in relation to
obesity risk. No convincing
evidence that age of CF is
related to obesity risk or CVD
risk.
Some evidence but limited that
delayed introduction of CF
beyond 4–6 months reduces
allergies in infants (both normal
and high risk infants)
Insufficient data to make
conclusion
Not addressed.
CF introduced after 4 months
does not impact on renal
function.
Not addressed.
CF introduced from 4 months is
not associated with adverse
renal function
Insufficient evidence to show
that age of introduction of CF
impacts on risk of obesity; no
evidence that age of CF has
effect on risk for T2D.
Any BF (including EBF) for
longer than 4 months is
protective against overweight
and obesity in childhood.
Insufficient data to make
conclusion on age of CF and risk
of obesity, CVD, T2D. Some
evidence that BF has protective
effect.
Few studies examining the age
of CF as independent risk factor
for atopic diseases. No
conclusion on appropriate age
for CF.
Yes, possible increased risk of
allergy with introduction of solids
outside the 4–6 month period.
Introduction of gluten and other
food allergens at 4–6 months
(while breastfeeding) may have
protective effects against CD and
T1DM.
Progressive introduction of
gluten between 4 and 6 months
(while BF) may reduce risk of CD
and T1DM.
Increased risk of eczema if CF
introduced at <4 months.
Insufficient or limited evidence
that risk of asthma and gluten
intolerance are associated with
timing of CF.
Not addressed.
Age of CF not specially
addressed. Infectious outcomes
considered in terms of exclusive
versus partial BF
Breastfeeding protects against
infectious morbidity. Introduction
of CF at 3 months or less may
increase risk of infectious
morbidity.
Any BF (including EBF) is
protective against AOM
Insufficient evidence to make
conclusion on association of CF
and infectious disease. Evidence
of association primarily based of
protective effects of BF.
18
Yes, possible increased risk of
allergy with delayed introduction
of solids (i.e. later than 4–6
months)
KEY FINDINGS: EVIDENCE THAT SOLID FOOD INTRODUCTION AT ‘AROUND 6 MONTHS’ MAY CONTRIBUTE TO ADVERSE HEALTH OUTCOMES
ESPGHAN1
Dental health
1
No conclusions on risk of caries
and age of CF
EFSA (2009)1
HORNELL ET AL (2013)2
No evidence that age of CF is
related to having caries.
Not addressed.
CONCLUSION BASED ON
COMBINED FINDINGS OF
THESE REVIEWS
Insufficient data to make
conclusion
Both ESPGHAN and EFSA define CF as the period when complementary foods are given together with either human milk or a breast milk substitute.
disease, asthma and allergy were the only health outcomes that were examined specifically in relation to introduction of CF (other health outcomes examined were in
relation to duration of breastfeeding, as noted).
2 Atopic
19
Attachment 2: Allergy and association with age of complementary feeding
Table A2.1 Summary of primary studies investigating the link between age of introduction of solid foods and risk of food-related allergy, allergic diseases and
syndromes. Studies were selected as described in Section 3.2. Columns on far right indicate where study has been cited by major review publications. See
References for citation details. BF = any breast feeding; EBF = exclusive breastfeeding; FF = formula-feeding; CF = complementary feeding.
Age
Cited by 2
Study
Type &
Exposure variable
1
N
Effect assess
Outcome
(location)
Population
(foods introduced; time period)
ES A N EF PP
ed
Evidence shows early (before 4 mo) increases risk of allergic disease
1981
Cohort ±
1265 E
2 yr
Solid foods at before/after 4 mo in
Solid foods introduced before 4 mo increases
Fergusson
parental
breastfed and formula-fed infants
risk of E in both breastfed and formula-fed

(New
history of
infants
Zealand)
atopy
1983
Kajosaari
(Finland)
1990
Fergusson
(New
Zealand)
1991
Kajosaari
(Finland)
1994
Kajosaari
(Finland)
2004 Morgan
(UK)
Cohort w/
history of
atopy
Cohort;
Normal allergy
risk
135
Cohort w/
history of
atopy
Cohort w/
history of
atopy
Cohort; preterm infants
135
1265
135
257
E, FA
E
1 yr
0-10 yr
AD,
FA
5 yr
E, FA
1 yr
E
Solid foods introduced at 3 mo
compared to 6 mo to EBF infants
Early solid food introduction (3 mo compared
to 6 mo) increases risk of E, FA
Various foods at before/after 4 mo
Solids introduced before 4 mo increases risk
of E
Solid foods introduced at 3 mo
compared to 6 mo to EBF infants
Solid foods introduced at 3 mo
compared to 6 mo to EBF infants
At 1 yr, delayed solid foods to 6 mo
(compared to 3 mo) reduces risk of E, FA but
no difference at 5 yr.
Delayed solid foods to 6 mo (compared to 3
mo) reduces risk of E, FA
Solid foods before 17 weeks
Introduction of 4 or more solid foods before
compared to after 17 weeks in
17 weeks increased risk of E
EBF, BF, and FF infants
Evidence shows no association (protective or adverse effects) between age of introduction and risk of allergic disease
1983
Cohort;
1110 A, W
0-4 yr
Solid foods before 4 mo compared
No association between solids introduced
Fergusson
Normal allergy
to after 4 mo in EBF and BF infants before 4 mo and risk of A; BF in first 4 mo
(New
risk
does not reduce incidence of A.
Zealand)
2002
Cohort; w/
1321 AD
1 yr
Egg/milk introduced before 4 mo
Age of introduction of solid foods was not
Schoetzau
history of
compared to after 4 mo
associated with incidence of AD

 



1 yr
20



Study
(location)
2004 Zutavern
(UK)
2006 Zutavern
(UK)
2009 Kramer
(Belarus)
2011 Chuang
(Taiwan)
2006 Tarini
Type &
Population
atopy
Cohort;
Normal allergy
risk
Cohort ±
allergic
symptoms
Cohort
Cohort;
Normal allergy
risk
Systematic
review
Age
Effect assess
ed
Exposure variable
(foods introduced; time period)
W, A,
E
5.5 yr
Various foods at time points
between 3 and 9 mo
AD,
AS
2 yr
2951
AD
6.5 yr
1877
3
AD
18 mo
N
605
2612
1
Cited by 2
Outcome
Egg and milk introduced before 6
mo compared to after 6 mo
No evidence that later introduction protects
against W, A, E. Increased risk of E with
eggs at > 8 mo.
No evidence that introduction of solids after 6
mo reduces risk of AD, AS
EBF for 6 mo compared to EBF for
3 mo then introduce solids or milk
Solid foods before 4 mo, between
4–6 mo, and after 6 mo.
No association between EBF duration or age
of solid food introduction and A
No association between age of introduction
and risk of AD
N/A
ES A N EF PP
 

 


E, AS, 1-10 yr 13 cohort studies; some with family Evidence for risk of allergy with solids at < 4
W, FA,
history of allergy
mo is inconsistent (possible increased risk for

AR,
E with solids at < 4 mo)
AD
Evidence that introduction of solid foods at around 6 months (i.e. after 4 mo and before 7 mo) is associated with decreased risk (or no increased risk) of allergic
diseases
2006 Poole
Cohort;
1612 FA
1-4yr
Wheat introduced before 6 mo
Cereal grain/rice introduced after 6 mo

(USA)
Normal allergy
(wheat
compared to after 6 mo
increased risk of wheat allergy
risk
)
2008 Snijders
Cohort;
2558 AD,
2 yr
Solid foods introduced before 7 mo Solids introduced after 7 mo increases risk


(Netherlands)
Normal allergy
AS
compared to after 7 mo
for E, AD, AS, but not FS
risk
2007 Filipiak
Cohort, ±
4753 E
4 yr
Various foods introduced before 4
Delayed introduction of solids after 4 months
(Germany)
allergy risk
mo, during 5-6 mo and after 7 mo
or, for highly allergenic foods (e.g. nuts) after

 
6 months of age decreases risk of E
compared to introduction after 7 months.
2008 Zutavern Cohort; ±
2073 A, AR, 6 yr
Solid foods before 4 mo, from 4–6
Solid foods introduced after 4 mo increases
(UK)
allergic
AS
mo, and after 6 mo. (“late
risk of FS, E. No association between solid


symptoms
introduction” means after 4 or 6
foods introduced at 4–6 months and risk of A,
mo)
AR.
2010 Koplin
Cohort;
2589 FA
12 mo Egg introduced 4–6 mo compared
Introduction after 6 mo associated with

(Australia)
Normal allergy
to after 6 mo
increased risk of egg allergy
risk
21
Study
(location)
Type &
Population
2010
Hesselmar
(Sweden)
2010 Nwaru.
(Finland)
Cohort;
Normal allergy
risk
Cohort; ±
diabetes risk
184
2010 Virtanen
(Finland)
Cohort;
Normal allergy
risk
Cohort; ±
atopic risk
Cohort; ±
atopic risk
Cohort; at-risk
for T1DM
1293
2013 Nwaru
(Finland)
2013 Nwaru
(Finland)
2013Frederiks
en
(USA)
2013 Palmer
(Australia)
N
994
3781
Age
Effect assess
ed
A, E
18 mo
1
AS
A
5 yr
5 yr
3781
A,
AD,E
AS
2 yr &
5 yr
5 yr
1835
D
From 9
month
s
8 & 12
mo
Cited by 2
Exposure variable
(foods introduced; time period)
Outcome
Fish introduced over various ages
in first year
16% increased prevalence of E for every 2
mo delay in fish introduction
Various foods introduced from 4 to
10 months
Late introduction of potatoes (>4 mo), oats
(>5 mo), rye (>7 mo), wheat (>6 mo), meat
(>5.5 mo), fish (>8.2 mo), and eggs (>10.5
months) increases risk allergic sensitisation.
Early introduction of oats (<5.5 mo)
decreases risk of A compared to introduction
after 5.5 mo
Early introduction (time specific to each food)
decreases risk of A, AD, E
Early introduction (time specific to each food)
decreases risk of AS
Risk of T1DM was increased at early (<4
months) or late (≥6 months) exposure times
compared to 4-5 months
Incidence of egg allergy lower with egg
exposure from 4 months compared to 8
months.
Various foods over first year; Oats
introduced before and after 5.5 mo
Various foods from 3–7 mo.
Various foods at 3–11 mo to EBF,
BF and FF infants.
Various foods introduced at <4
months and ≥6 months
RCT; with
86
FA
Daily egg powder compared to rice
mild-severe
powder fed between 4–8 months
eczema
Evidence or age range for solid food introduction not applicable to P274 assessment
2006 Kull
Cohort;
2614 A, AR, 4 yr
Fish at before 9 months (3– 8
(Sweden)
Normal allergy
AS, E
months) compared to 9 mo
risk
2009 Alm
Cohort;
4953 E, FA
12 mo Fish introduced before 9 mo
(Sweden)
Normal allergy
compared to after 9 mo
risk
2011 Joseph
Cohort; ±
594
AD,
2 yr
Solid foods before 4 mo compared
(USA)
allergy risk
AS
to after 4 mo
3-8 mo group had reduced risk for A, E, AR,
AS
ES A N EF PP





Early introduction decreases risk of eczema

For infants with parental history of allergy,
peanut sensitisation and possibly egg was
reduced in infants exposed at <4mo
abbreviations: A = asthma; AD = atopic disease; AR = allergic rhinitis; AS – allergic sensitization; At = atopy; C = celiac disease; T1DM = type 1 Diabetes Mellitus; E =
eczema; FA = food allergy; FS = food sensitization; W = wheezing
2Review abbreviations: ES = ESPGHAN (2008); A = AAP (2008); N = NHMRC (completed 2008, published 2013); EF = EFSA (2009); PP = Palmer and Prescott (2012).
1Effect
22

Table A2.2
Studies included in reviews or advice on the relationship between timing of solid food introduction and development of
allergy a
Reviewed by b
NHMRC IFG
NHMRC ADG
ESPGHAN
AAP
EFSA
ASCIA
FSANZ
Review or advice published (year)
2013
2013
2008
2008
2009
2010
2013
Literature searched until (year)
N.S.
N.S.
N.S.
N.S.
N.S.
N.S.
2013
Latest study included in review (year)
2010
2008
2007
2006
2008
2008
2013
No. of studies on which conclusions are based:
10
7
11
7
11
7
33
Published < 2002
0
0
2
3
4
0
6
Published 2002-2008
7
7
9
4
6
7
13
Published >2008
3
0
0
0
1
0
14
No. that were not primary data
1
1
5
0
2
6
0
Breakdown:
a
Noting that SD1 also summarised 3 reviews covering other health effects associated with the timing of solid food introduction. Development of allergies & allergic disease is
the only health effect for which there appeared to be current debate and significant new research indicating risk.
b Abbreviations:
NHMRC = National Health and Medical Research Council; IFG = Infant Feeding Guidelines; ADG = Australian Dietary Guidelines; ESPGHAN = European
Society for Paediatric Gastroenterology, Hepatology, and Nutrition; AAP = American Academy of Pediatrics; EFSA = European Food and Safety Authority; ASCIA =
Australasian Society of Clinical Immunology and Allergy; N.S = not specified.
23
Attachment 3: Summary of issues considered in
FSANZ risk assessments relating to the age of
introduction of solid foods
Date of
assessment
Issues considered
Conclusions
August
2008
Potential for displacement of
breast milk and/or formula, any
changes in energy intake, and
whether growth outcomes are
adversely affected
Intervention studies showed introduction of solids
at three-four months of age reduced breast milk
intake but does not significantly affect the rate of
increase in weight and length of the infant
Capacity of infant kidneys to
deal with the higher solute load
of solid foods prior to six
months of age
Unable to identify any studies that directly
assessed changes in renal solute load or water
balance with introduction of solid food, but
greatest risk of negative water balance is during
illness. However, the capacity of infants to reduce
intake of solid foods during illness is likely to
mitigate potential risk
Impact on iron and zinc status,
particularly in pre-term infants
Evidence from 2 studies provides some indication
that exclusive breastfeeding to 6 months does not
increase risk of iron deficiency at a later age.
Expected that the outcomes on zinc status would
be similar to, and no worse than, those for iron, as
infants have a better storage of zinc compared to
iron in the first 6 months of life
Influence of feeding practices
in infancy on later food
preferences
Emerging evidence suggesting that the timing of
solid food introduction can influence later dietary
outcomes and preferences, but it is too early to
draw conclusions about the impact this might have
on recommended infant feeding practices
Risk of allergy and other
immune-mediated diseases
Evidence regarding the timing of the introduction
of solids and risk of allergy and other immunemediated diseases, such as coeliac disease and
Type 1 diabetes, is emerging and no firm
conclusions can be drawn at this time. However,
preliminary indications are that the risk of allergy
may be minimised if breastfeeding is maintained
throughout the period of introducing solids,
whereas the risk may increase if the introduction
of solids is delayed beyond seven months
Conclusion
Delaying introduction of solid foods to around
six months of age is unlikely to have any
discernible positive or negative effect on the
nutritional or developmental outcomes of
infants.
24
Date of
assessment
Issues considered
Conclusions
October
2013
Risk of iron and zinc
deficiencies in preterm infants
with delayed introduction of
solids
Unable to identify any studies addressing this
Allergy risk – less than 4
completed months (~17 weeks
of age)
Allergy risk appears to be associated with solid
foods introduced at < 4 months. This association,
combined with evidence that risk of infectious
morbidity is also increased with this time period
(as related to the protective effects of
breastfeeding), supports the current
recommendations from ESPGHAN, EFSA, and
NHMRC that from 4 months of age is the
appropriate minimum age at which solid foods are
introduced.
Allergy risk – 7 months or
above
Since 2008, there is increasing evidence that the
timing of solid food introduction may be related to
the development of food-related allergy. Critical
period to minimise the risk of allergy development
seems to be between 4 and <7 months. However,
because of unclear and inconsistent definitions of
age categories, measurement bias in many
studies and the contribution of various other
factors in the development of allergic disease, the
evidence is not conclusive.
Conclusion
‘Around 6 months’ as the appropriate age for
the introduction of solid food to infants, would
have minimal effect on the risk of adverse
health outcomes, when compared to ‘from 4
months’ of age
Proportion of infants being
introduced to solids at <4
months
The Australian national average proportion of
infants who were receiving solids before 4
completed months of age was 4–10%, noting that
within this range there is some variation according
to maternal age and SES (2010 Infant Feeding
Survey). New Zealand data (2011/12) indicates
that the proportion of infants introduced to solids
before 4 months was 10%, which was lower than
previous survey (2006/07) of 16%.
Introduction of solids and
cessation of breast feeding
Data on infant feeding practices in Australia
indicates there is little association between the
introduction of solid foods and continuation
breastfeeding. Between 4–6 months of age, the
prevalence of any breastfeeding declined from
69% to 60% while the prevalence of feeding solids
rose from around 10% to over 90%. Similarly,
before 4 months of age, the decline in prevalence
of breastfeeding was double the prevalence of
introducing solids (2010 Infant Feeding Survey) .
January
2014
25
Date of
assessment
July 2014
Issues considered
Conclusions
Conclusions
Current evidence indicates that in developed
countries with generally hygienically prepared
foods, there is no additional risk from delaying
the introduction of solids until around 6
months or, conversely, from introducing solids
closer to the 4 month end of the window, ie.
between 4 and <7 months.
Gastrointestinal infection
Large UK cohort study identified no association
between age of introduction of solids and
hospitalisation for gastrointestinal or respiratory
tract infections in the first 8 months of life.
Overall conclusion
In Australia and New Zealand, there is no
overall difference in risk between introducing
solids from 4 months of age relative to around
6 months of age (ie within window from 4
months to <7 months of age).
26
Attachment 4: Basis of NHMRC guidelines for infant
feeding
FSANZ’s risk assessment conclusion supported a window for introducing solids from 4–<7
months. This is consistent with the current labelling requirements and also with the infant
feeding guidelines of ‘around 6 months’ in both countries. However, the minimum age
labelling permission ‘from 4 months‘, and the recommendations in the guidelines ‘introduce
solids at around 6 months‘ appear to be inconsistent with each other. Therefore, FSANZ
liaised with the NHMRC in 2014 to identify commonalities in the assessments undertaken
and to understand reasons for the apparent differences between the agencies’ use of their
respective assessments.
The New Zealand guidelines also recommend complementary food at ‘around 6 months’ but
emphasise that developmental cues are a key indicator of readiness for solids and that the
timing of this varies between individual infants. The New Zealand guidelines were released
in 2008 (Ministry of Health 2008), whereas the NHMRC undertook a literature review
including evidence up to 2010 (NHMRC 2012b) and FSANZ has also reviewed more recent
evidence. Therefore, this discussion focuses on the evidence assessed by FSANZ and
NHMRC, rather than the New Zealand guidelines.
The NHMRC advice for ‘around 6 months’ is a risk management conclusion that takes into
account the food-health outcome evidence assessed, the development of infants, and the
need to provide general population advice on the likely optimal feeding of infants, including
the importance of continued breastfeeding. This is different to FSANZ’s purpose which is to
ensure the provision of adequate information regarding suitability e.g. consistency, of a
packaged solid food, so that consumers can make an informed choice.
The summary of evidence statements below are excerpted from evidence base used to
support the Infant Feeding Guidelines. In almost all cases, both the Infant Feeding
Guidelines Advisory Committee and FSANZ interpreted this evidence in the same way.
Statements with grades6 were based on a systematic review of the literature up until 2010. In
some cases, additional material published subsequently was also referred to in the
guidelines.
NHMRC evidence statements for ages relevant to the Proposal (i.e. 4–<7 months), were
(NHMRC 2013, page 89):
“Infants, from either developing or developed countries, who are exclusively breastfed for 6
months or longer do not have deficits in growth compared to those who are not
exclusively breastfed.” (Grade B)
“There are no apparent risks in a general recommendation for exclusive breastfeeding for
the first 6 months of life, in both developing and developed countries. However, infants
should still be managed individually in order to achieve sufficient growth and minimise
adverse outcomes.” (Grade B)
“Infants who are exclusively breastfed for 6 months experience less morbidity from
gastrointestinal infection than those who are mixed breastfed as of 3 or 4 months.”
(Grade B)
6
Grades for evidence statements were graded A to D according to standard NHMRC protocols. See page 5 of
the NHMRC Dietary Guidelines (NHMRC 2013)
27
FSANZ agrees with the first two of these conclusions. The third conclusion is discussed
below.
Additional food-health outcome relationships were examined by the Committee and these
received a D grade.
“Evidence of an association between the age of introduction of solid foods and risk of
overweight in children younger than age 7 years is inconclusive” (Grade D) (NHMRC
2012a, page 87)
“Delaying the introduction of solid foods until after the age of 6 months is associated with
increased risk of developing allergic syndromes.” (Grade D) (NHMRC 2012a, page 90)
Other conclusions were reached from other evidence sources. Those that relate only to solid
foods and not to breastfeeding versus formula feeding include (NHMRC 2012a, page 86):
“By around 6 months of age breast milk (or infant formula) no longer provides sufficient
nutrients and energy for growth and development.”
“By around 6 months of age most infants are able to adapt to different foods, food textures
and modes of feeding.”
“If solid foods are introduced while the tongue-extrusion reflex is still strong, the infant will
reject the spoon (a hard object) – the mother might then feel that the infant is rejecting
the food, when in fact he or she is rejecting the object in the mouth”.
There were a number of other conclusions based on these evidence sources. However,
these were largely derived from studies comparing infant formula to breast milk or exclusive
to non-exclusive breastfeeding. Hence the results cannot be extrapolated to the comparison
of the effect of introducing solids from 4 months compared with ‘around 6 months’. Relevant
conclusions were:
“Breastfeeding exclusively to around 6 months is compatible with achieving the lowest rates
of allergic disease.” (emphasis added) (NHMRC 2012a, page 16)
“The introduction of complementary feeding (adding solid foods and liquids other than breast
milk or infant formula) at around 6 months is consistent with introduction of solid foods
during the probable ‘window of tolerance’ between 4 and 7 months. The majority of
Australian infants have solids introduced during this period.” (NHMRC 2013, page 90)
“Animal and human studies suggest that breastfeeding during the period of antigen
introduction facilitates the development of oral tolerance, with transforming growth
factor-beta (TGFß) a possible critical component in this process and protective against
allergic asthma.” (NHMRC 2012a, page 16)
28
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32